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Clinical Trials/NCT01761435
NCT01761435CompletedPhase 3

Randomized, Comparative and Prospective Clinical Trial Evaluating Efficacy and Safety of a Dose of Seasonal Flu Vaccine Compared to Two Doses of Vaccine for Prevention of Influenza in Solid Organ Transplant Recipients

Fundación Pública Andaluza Progreso y Salud13 sites in 1 country499 target enrollmentStarted: October 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
499
Locations
13
Primary Endpoint
Seroconversion rates
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Randomized, multicenter, open label trial to compare safety and efficacy of two doses stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.

Detailed Description

The purposes of this study are:

  1. Evaluate the efficacy and safety of a double dose of seasonal flu vaccine compared to a single dose.
  2. Determine the specific cellular immune response produced after the first and second vaccine doses of seasonal flu vaccine by in vitro stimulation of specific memory cells (A and B flu viruses).
  3. Evaluate the humoral immune response produced after one dose vs two doses of seasonal flu vaccine by the measure of serum antibody levels.
  4. Evaluate clinical efficacy of stationary flu vaccine in solid organ transplant recipients.
  5. Evaluate a long term cellular and humoral response(1 year) of seasonal flu vaccine.
  6. Characterize the genetic expression profile of immune response after the flu vaccine in solid organ transplant recipients by means of a genetic sub-study.
  7. Characterize the flu vaccine effect (one dose and two doses) through the antibody anti-HLA(human leukocyte antigen), and its influence on the rejection rate in solid organ transplant recipients, by means of immunologic sub-study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Solid organ transplant recipient.
  • •16 years or older.
  • •More than 30 days after transplantation.
  • •Negative pregnancy test for women of childbearing potential
  • •The patient must give informed consent

Exclusion Criteria

  • •No written informed consent.
  • •Acute rejection within 15 days prior to vaccination.
  • •Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins.
  • •History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).

Outcomes

Primary Outcomes

Seroconversion rates

Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose

Difference in seroconversion rates in both treatment groups at 5, 10, 15 weeks, and 12 months after the first vaccine dose (percent of patients with 4 x increase in the pre-vaccination titers).

Secondary Outcomes

  • Antibody anti-HLA(At 5, 10, 15 weeks, and 12 months after the first vaccine dose)
  • Efficacy(At 5, 10, 15 weeks, and 12 months after the first vaccine dose)
  • Cellular response(At 5, 10, 15 weeks, and 12 months after the first vaccine dose)
  • Safety.(At 5, 10, 15 weeks, and 12 months after the first vaccine dose)
  • Clinical complications(At 5, 10, 15 weeks, and 12 months after the first vaccine dose)
  • Postvaccination antibody titers(At 5, 10, 15 weeks, and 12 months after the first vaccine dose.)

Investigators

Sponsor
Fundación Pública Andaluza Progreso y Salud
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (13)

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